Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
- Registration Number
- NCT03641794
- Lead Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Brief Summary
This is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid tumor cells more effectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- Age greater of 18 years and less than 45
- Weight ≥50 kg,body mass index of 19~26 kg/m2
- Signed ICF
Exclusion Criteria
- active autoimmune disease
- uncontrolled concurrent illness
- Smoking
- Drugs
- positive serology for HIV, Hepatitis B or C,Syphilis
- Pregnancy or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg DN1406131 DN1406131 25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg
- Primary Outcome Measures
Name Time Method adverse events - type, incidence, severity 28 day Evaluate the safety and toxicity of DN1406131 in healthy volunteers
Maximum Tolerated Dose 14 day To define the Maximum Tolerated Dose (MTD)
- Secondary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) 48 hours Cmax
Serum for biomarkers of IDO activity (kynurenine and tryptophan) 48 hours Evaluation of serum for biomarkers of IDO activity (kynurenine and tryptophan), before and after initiation of therapy.
Pharmacodynamics（PD）Elimination half-life 48 hours T1/2
peak time 48 hours Tmax
Trial Locations
- Locations (1)
PKUCare Luzhong Hospital
🇨🇳Zibo, Shandong, China